LivaNova Gets Twin FDA Approval To Treat Drug Resistant Epilepsy

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LivaNova was able to grab twin U.S. Food and Drug Administration approvals for an implantable generator and a programming system, which created its Vagus Nerve Stimulation Therapy System, used for the treatment of drug-resistant epilepsy. Majority of the time, epilepsy is treated with anti seizure drugs, though people with epilepsy sometimes possess a drug-resistant form of the disorder. Physicians could potentially prescribe patients to change their lifestyle habits, medical devices and even surgery if it’s needed.

The SenTiva implantable generator and VNS Therapy Programming System—which entails a handheld wireless device and user interface on a tablet—creates a physician-focused customizable therapy for patients with drug-resistant epilepsy, the company reported in a statement.

Sentiva was created to deliver stimulation to the vagus nerve to halt a seizure, as well as to prevent seizures prior to them happening, the company added. The device can also record information connected with seizures, including variations in heart rate and body positions.

“We created SenTiva and the accompanying VNS Therapy Programming System based on feedback received from patients and physicians to ensure ease of use, better patient care, and cost-effectiveness,” stated Jason Richey, LivaNova’s president of North America and general manager of its neuromodulation business, in the statement.

“In addition, SenTiva’s compact size allows for a more comfortable experience for pediatric patients, which is beneficial now that VNS Therapy is the first and only system that is FDA approved for drug-resistant epilepsy in children as young as four years of age,” Richey concluded.

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